[Federal Register: October 24, 2007 (Volume 72, Number 205)]
[Notices]
[Page 60377-60378]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24oc07-105]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007P-0047]
Nonprescription Drugs Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Nonprescription Drugs Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on December 14, 2007, from
8 a.m. to 5 p.m.
Addresses: Electronic comments should be submitted to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
Select ``2007P-0047--Amend the Dosage of
Oral Phenylephrine Listed in the Final Monograph on Oral
Decongestants,'' and follow the prompts to submit your statement.
Written comments should be submitted to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852, by close of business on December 30,
2007.
Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The hotel telephone number is 301-
589-5200.
Contact Person; Diem-Kieu Ngo, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857,
301-827-7001, FAX: 301-827-6776, e-mail: Diem.Ngo@fda.hhs.gov, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301) 443-0572 in
the Washington, DC area), code 3014512541. Please call the Information
Line for up-to-date information on this meeting. A notice in the
Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
Agenda: The committee will discuss the safety and effectiveness of
phenylephrine hydrochloride and phenylephrine bitartrate as over-the-
counter (OTC) oral nasal decongestants. The discussion at the meeting
will address a citizen petition submitted to FDA on February 1, 2007
(Docket No. 2007P-0047/CP1), which asserts that the available data do
not support the adult and pediatric doses of phenylephrine
hydrochloride and phenylephrine bitartrate that are generally
recognized as safe and effective in the OTC drug monograph for Cold,
Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products
(CCABADP) in 21 CFR part 341. The meeting will focus on the review of
existing safety and efficacy data and the petitioner's request that the
CCABADP monograph be amended to increase the adult dose of
phenylephrine hydrochloride from 10 to 25 milligrams (mg) and that of
phenylephrine bitartrate from 15.6 to 40 mg.
Additional information was submitted to the docket for OTC Nasal
Decongestants (Docket No. 1976N-0052N; submissions EMC140, C251, C253
and Supplement 13) and is related to the petition or the petitioner's
publications. These submissions were submitted to the OTC Nasal
Decongestant docket and have been cross-referenced and linked to Docket
No. 2007P-0047. The petition and other relevant submissions can be
found at the following Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/dockets/07p0047/07p0047.htm
.
Other information in Docket No. 1976N-0052N may be considered. For
example, see comments 10 and 11 of the Tentative Final Monograph for
OTC Nasal Decongestants, published in the Federal Register of January
15, 1985 (50 FR 2220 at 2226).
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material will be
available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2007 and scroll down to the appropriate advisory committee
link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
November 30, 2007. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those desiring to make formal
oral presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before November 22, 2007. Time allotted for each presentation may
be limited. If the number of registrants
[[Page 60378]]
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by November 23, 2007.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Diem-Kieu Ngo at
least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/advisory/default.htm
for procedures on public conduct during advisory committee
meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: October 18, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. 07-5249 Filed 10-23-07; 8:45 am]
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